Circadian Rhythm Sleep-Wake Disorders, Shift Work Type, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
insomnia, shift work, circadian rhythm, sleep psychology, behavioral sleep medicine
Brief summary
The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.
Detailed description
Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.
Interventions
BEHAVIORALCBTI
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
BEHAVIORALMRTI
Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep
Sponsors
Oregon State University
American Academy of Sleep Medicine
Monash University
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current shift working nursing staff in Oregon * Expect to continue on shift work schedule during the study * Meets criteria for an insomnia disorder * Elevated insomnia symptoms * Have daily access to internet on a smartphone, tablet, or computer; and * Can read and write in English
Exclusion criteria
* People with uncontrolled medical conditions * Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety * Some current treatments for insomnia * Permanent day, evening, or rotating shift schedule * History of seizures or manic episode; or * Current/expected pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | At baseline and at the post-treatment assessment (occurring at approximately 10 weeks) | Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity |
| Retention Rate | At the post-treatment assessment (occurring at approximately 10 weeks) | Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\] |
| Session Attendance | At the post-treatment assessment (occurring at approximately 10 weeks) | For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\] |
| Implementation Assessment Measure | At the post-treatment assessment (occurring at approximately 10 weeks) | Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Severity Scale | At baseline and at the post-treatment assessment (occurring at approximately 10 weeks) | Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue. |
| Change in PROMIS Sleep Related Impairment 8 item | At baseline and at the post-treatment assessment (occurring at approximately 10 weeks) | Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Dietch, PhD
Oregon State University
Outcome results
None listed